TrialTracker_MD said:The shortage clause is the answer to the second question and it is a subtraction rather than an addition.
This is where I part company with the consensus forming above. A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to. It is a different legal universe with no pharmacy oversight, no patient relationship and no content guarantee, and conflating the two in these threads helps nobody.
If somebody has the primary source to hand I would rather cite it than paraphrase it.
AussieAnna said:My pharmacy stopped supplying with three weeks notice and a letter that explained nothing, so I went and read the statute.
Compounding pharmacy customer here with experience relevant to compounded supply.
I've ordered from 5 different compounding pharmacies over the past 18 months. The quality variation is real — purity ranged from 94% to 101% of label claim based on independent Janoshik testing.
My current compounder (a 503B facility) has been consistently 98-101% purity across 5 orders. I pay $144/month vs $1,314 for brand. The savings are substantial and the product is equivalent in my experience.
Re: compounded supply — this applies whether you're using brand or compounded. The clinical principles are the same.
InsuranceTom said:A research-chemical supplier selling lyophilised powder labelled research use only is not compounding and is not claiming to.
Compounding pharmacy response time test for compounded supply: I email customer service at odd hours to test responsiveness. A pharmacy that can't answer questions promptly is a red flag.
My current pharmacy: average response time 1 hour. They answered my questions about batch-specific COAs thoroughly and professionally.
Communication quality is a proxy for operational quality. A pharmacy that communicates well is likely manufacturing well too.
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Shop Reference StandardsFollowing on from tammy_FL — and this may be the naive question:
Why a shortage listing created a legal pathway at all, since a shortage is a supply fact rather than a permission?
OP back with an update, since a thread like this is useless without one.
The bulks-list asymmetry was the piece I had missed entirely. It explains why one of my two pharmacies is still arguing it can supply and the other simply stopped.